NCT04436224已完成4 期
Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation: A Dose-exploration and Effectiveness Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 530
- 试验地点
- 2
- 主要终点
- successful analgesic proportion
研究概览
简要总结
Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression and gastrointestinal motility. The study will further explore the continuous pumping-dose of hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma concentration as well as evaluates the safety and effectiveness of hydromorphone for ICU non-mechanical ventilation patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Non-mechanical ventilation patients with expected ICU stay time >24h
- •People with moderate to severe pain who need immediate analgesic treatment (NRS ≥ 4 or BPS ≥ 5 points, CPOT ≥ 3);
排除标准
- •During pregnancy or breastfeeding；
- •Confirmed acute severe intracranial or spinal nerve disease caused by vascular, infection, intracranial dilation or injury;
- •Non-compensatory acute circulatory failure (severe hypotension with MAP<55 mmHg even if sufficient fluid resuscitation and vascular compression therapy);
- •Severe bradycardia (heart rate<55 beats/min) or heart block of degree II-III (excluding those with pacemakers installed);
- •Unable to obtain pain scores or any other conditions that may seriously interfere with the collection of research data;
- •Have used analgesics other than remifentanil during mechanical ventilation in the ICU;
- •Having a history of long-term use of opioid drugs or opioid addiction;
- •Known allergy history of experimental drugs;
- •Suffering from severe or acute asthma, or respiratory depression caused by severe carbon dioxide retention, head injury, and intracranial damage;
- •Danger period intestinal obstruction (present or at risk of progression to gastrointestinal obstruction, especially in patients with paralytic intestinal obstruction);
- •Having participated in this study or any other intervention studies (any study that assigns patients to different treatment groups);
- •Unsuitable to participate in this experiment according to the judgment of the researchers.
研究组 & 干预措施
hydromorphone
Experimental
NS 40ML+ hydromorphone(10mg , 2mg:2ml），IV-Pump，loading dose 0.5-2mg，maintenance dose 0.50mg/h
干预措施: Hydromorphone (Drug)
fentanyl
Active Comparator
NS 40ML+ butorphanol(10mg, 1mg:1ml），IV-Pump，loading dose 1-2mg/kg，maintenance dose 0.7-10mg/kg/h
干预措施: Fentanyl (Drug)
Butorphanol
Active Comparator
NS 40ML+ fentanyl(0.5mg, 0.1mg:2ml），IV-Pump，loading dose 0.5-1mg，maintenance dose 0.08-0.2mg/h
干预措施: Butorphanol (Drug)
结局指标
主要结局
successful analgesic proportion
时间窗: From date of using the intervention drugs until the date of leaving from icu, up to 28 days
Proportion of patients in each group who reached the target analgesia score range
次要结局
- Adverse event(From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days)
- Score(From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days)
- dose of analgesics(From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days)
- ICU stay(from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days.)
- Days without delirium or coma(From date of using the intervention drugs until the date of discharge or death from any cause, up to 28 days)
- cost during ICU(from the date of entering hospital until the date of discharging or death from any cause，up to 60 days)
- Mechanical ventilation-free days(From date of using the intervention drugs until the date of retrachealing intubation,leaving icu or death from any cause, up to 28 days)
- Length of hospital stay(From hospital admission to hospital discharge or death, assessed up to 60 days.)
- Mortality rate in hospital(From hospital admission to hospital discharge or death, assessed up to 60 days.)
- ICU mortality(From ICU admission to ICU discharge or death, assessed up to 60 days.)
研究者
研究点 (2)
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